Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA)
NCT06940323
Summary
PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally. Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be blood, breast milk, infant stool, maternal stool and vaginal swab samples, collected at specific time points. (2) The online surveys will be collected at specific time points. All study activities will be discussed with participants upon enrollment. By collecting this information, the investigators hope to gain deeper insights into the relationship between pregnancy, the neurological condition, and maternal and infant health. For example, one of the sub-studies focuses on breast milk collection for women planning postpartum treatment with Ocrevus, Rituxan, Briumvi or Kesimpta. This study is fully remote and all sample collection is optional, so participants can choose which types of samples they wish to provide. For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient. The investigators aim to enroll women with chronic neurological conditions who are planning pregnancy, currently pregnant, or within one year postpartum.
Eligibility
Inclusion Criteria: * Pregnant or contemplating pregnancy * Female, aged 18 to 64 years * Diagnosis of one of the following conditions: * Clinically Isolated Syndrome (CIS) or Multiple Sclerosis (MS), based on the 2010 McDonald Criteria * Neuromyelitis Optica Spectrum Disorder (NMOSD) * Inflammatory Bowel Disease (IBD) * Rheumatoid Arthritis (RA) * Myasthenia Gravis * Lupus * Other chronic neurological conditions * Willing to provide biosamples and/or complete surveys at specified timepoints * Women without a chronic condition who are pregnant or contemplating pregnancy (as part of the control group) Exclusion Criteria: \- Unwillingness to provide informed consent
Conditions5
Locations1 site
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NCT06940323